Text Size

Efficacy Study of Dasatinib in Locally Advanced Triple-Negative Breast Cancer Patients

This study has been terminated.
(terminated due to futility after interim analysis)
Sponsor:
Collaborator:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
Baylor Breast Care Center
ClinicalTrials.gov Identifier:
NCT00817531
First received: January 5, 2009
Last updated: August 27, 2012
Last verified: August 2012
History of Changes
Results First Received: May 7, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Breast Cancer
Intervention: Drug: Dasatinib

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study started recruitment in December 2010. Baylor college of Medicine is the only site of the study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
each patient have to be eligible and pass all screening tests after signing the consent to be enrolled in the study.

Reporting Groups
  Description
Dasatinib Patients took Dasatinib 100mg daily

Participant Flow:   Overall Study
    Dasatinib  
STARTED     22 [1]
COMPLETED     20 [2]
NOT COMPLETED     2  
Adverse Event                 1  
Lack of Efficacy                 1  
[1] 22 patients were eligible for this study and started the treatment.
[2] 20 out of 22 patients finished study treatment. 2 patients stopped the treatment after the 1st week.



  Baseline Characteristics
  Hide Baseline Characteristics

Reporting Groups
  Description
Dasatinib Patients took Dasatinib 100mg daily

Baseline Measures
    Dasatinib  
Number of Participants  
[units: participants]
 		  22  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     20  
>=65 years     2  
Age  
[units: years]
Mean ± Standard Deviation 		  48.5  ± 12.7  
Gender  
[units: participants]
 		 
Female     22  
Male     0  
Region of Enrollment  
[units: participants]
 		 
United States     22  



  Outcome Measures

1.  Primary:   Clinical Efficacy   [ Time Frame: Assessment at pre-surgery or 3 to 4 weeks of treatment. ]
  Show Outcome Measure 1


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The study was terminated after internal analysis due to treatment futility. It does not meet the required number of responses to continue the study.  


Results Point of Contact:  
Name/Title: Dr. Mothaffar Rimawi
Organization: Baylor College of Medicine
phone: 713-798-1311
e-mail: rimawi@bcm.edu


No publications provided


Responsible Party: Baylor Breast Care Center
ClinicalTrials.gov Identifier: NCT00817531     History of Changes
Other Study ID Numbers: H 21592
Study First Received: January 5, 2009
Results First Received: May 7, 2012
Last Updated: August 27, 2012
Health Authority: United States: Food and Drug Administration